Drotrecogin alfa (activated)
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Xigris | — | 2011-11-28 | europa.eu ↗ |
| Approved | EU (EMA) | Xigris | — | 2002-08-22 | europa.eu ↗ |
Trials 15 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01411670 Comparator | Jan 2011 → Feb 2015 | infectious disease with sepsis | University of Roma La Sapienza | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00625209 Comparator | Mar 2008 → Jun 2015 | infectious disease with sepsis | University of Versailles | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00049777 Background | Dec 2002 → Aug 2005 | infectious disease with sepsis | Eli Lilly and Company | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | drotrecogin-alfa (activated) | “INTRODUCTION: The aim of our study was to evaluate the clinical impact of the administration of intravenous steroids, alone or in conjunction with drotrecogin-alfa (activated)...” PMID 25928214 ↗ Apr 201513“A decade after drotrecogin alfa (activated) (DAA) was released on the market worldwide, its benefit-to-risk ratio remains a matter of debate.” PMID 23525934 ↗ May 2013 |
| Known as | Activated protein C | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01017107 ↗ |
| Known as | APC | “The intervention consisted of APC (N = 16) administered intravenously for 96 hours with a dose of 24 μg/kg/hour or placebo (N = 16) with a similar infusion rate.” PMID 20663207 ↗ Jul 2010 |
| Known as | DAA | “A decade after drotrecogin alfa (activated) (DAA) was released on the market worldwide, its benefit-to-risk ratio remains a matter of debate.” PMID 23525934 ↗ May 2013 |
| Known as | DrotAA | “INTRODUCTION: The aim of our study was to evaluate the clinical impact of the administration of intravenous steroids, alone or in conjunction with drotrecogin-alfa (activated)...” PMID 25928214 ↗ Apr 20154“INTRODUCTION: Early multimodal treatment of severe sepsis, including the use of drotrecogin alfa (activated) (DrotAA) when indicated, is considered essential for optimum outcome.” PMID 19457240 ↗ May 2009 “Patients with severe sepsis frequently receive prophylactic heparin during drotrecogin alfa (activated) (DrotAA) treatment due to risk of venous thromboembolic events (VTEs).” PMID 17556722 ↗ Jun 2007 “Drotrecogin alfa (activated) (DrotAA) is used for the treatment of adults with severe sepsis who have a high risk of dying.” PMID 17350452 ↗ Mar 2007 “Administration of Drotrecogin Alfa [Activated] [DrotAA] in Early Stage Severe Sepsis” PMID 18786266 ↗ Sep 2008 |
| Known as | Recombinant Activated Protein C | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02885168 ↗ |
| Known as | Xigris | “Xigris (drotrecogin alfa activated) is a recombinant form of human activated protein C” NCT01227187 ↗ |
| Action | Inhibit | “DAA infusion enhances the inhibition of fibrin formation.” PMID 21241489 ↗ Jan 2011 |
| Modality | Protein / enzyme biologic | “a recombinant form of human activated protein C” NCT00045760 ↗ |
| Route | Intravenous | “96-hour intravenous infusion of drotrecogin alfa (activated)” NCT00045760 ↗ |